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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K173093
Device Name TAMA BEMS device
TAMA Research Corporation
7600 North 16th Street,
Suite 205
Phoenix,  AZ  85020
Applicant Contact Ali Shambayati
Medical Devices Academy, Inc.
345 Lincoln Hill Road
Shrewsbury,  VT  05728
Correspondent Contact Robert Packard
Regulation Number882.5890
Classification Product Code
Date Received09/29/2017
Decision Date 06/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No